NCT01603719

Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

Safety and Efficacy of an Infant Starter Formula With Prebiotics (GOS) and a Higher Content of Beta-palmitate on Stool Characteristics, Food Tolerance, Calcium Uptake, and Incidence of Infectious Disease in the First Year of Life

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Waldkrankenhaus Protestant Hospital, Spandau · Academic / Other
• Sex: All
• Age: 10 Days
• Healthy volunteers: Accepted

Summary

The purpose of this clinical trial is to evaluate the effect of a new infant starter formula with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.

Detailed description

An experimental infant formula with added prebiotics (GOS) and with a higher content of palmitic acid esterified in beta-position is to be tested in a double-blinded randomized controlled trial. The addition of prebiotics to an infant formula should favor growth of a beneficial bifidogenic intestinal flora and have positive effects on immunity, promote softer stool formation and short chain fatty acid content in the stools. Higher proportion of beta-palmitic acid esterified in 2nd position of the triglyceride should reduce formation of fatty acid-calcium soaps in the stools and promote calcium and fat absorption in the gut, therfor reduce symptoms of constipation and colics.

Conditions

• Infections
• Stool Flora
• Stool Biochemistry
• Constipation
• Food Intolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	new infant formula with prebiotics and beta-palmitate	experimental infant formula as sole source of nutrition over first 12 weeks of life

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-10-01
• Completion: 2020-01-01
• First posted: 2012-05-23
• Last updated: 2020-06-09

Locations

1 site across 1 country: Germany